Executive Summary:
This notification, issued by the Ministry of Health and Family Welfare on October 30, 2018, prohibits the use of Antibody Detecting Rapid Diagnostic Tests for the routine diagnosis of malaria. The decision follows recommendations from an Expert Committee, citing the impracticality and unreliability of these tests for acute malaria diagnosis. This amendment is made under the powers conferred by section 10A of the Drugs and Cosmetic Act, 1940.
Key Points / Main Content:
* **Prohibition of Antibody Detecting Rapid Diagnostic Tests:**
* The Central Government prohibits the use of Antibody Detecting Rapid Diagnostic Tests for routine malaria diagnosis.
* **Justification:**
* Antibody detection is not practical for acute malaria diagnosis due to the time required for antibody development and their persistence after infection clearance.
* Serologic testing does not detect current infection but measures past exposure.
* High false positive rates in endemic areas with patients having fever due to other reasons.
* Expert Committee found no justification for using these tests for acute malaria diagnosis.
* **Amendment Details:**
* This amends the Government of India's notification No. G.S.R. 577E, dated July 23, 1983.
* The amendment inserts "Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria" after serial number 12 in the table of the said notification.
Impact Analysis:
* **Healthcare Providers/Diagnostic Centers:**
* Impact: Must discontinue the use of Antibody Detecting Rapid Diagnostic Tests for routine malaria diagnosis.
* Action Required: Implement Antigen Detecting Rapid Diagnostic Tests and blood smear examination for malaria diagnosis.
* **Patients:**
* Impact: Will no longer be subjected to Antibody Detecting Rapid Diagnostic Tests for malaria diagnosis.
* Action Required: Should expect Antigen Detecting Rapid Diagnostic Tests and blood smear examination for malaria diagnosis.
* **Central Government/Ministry of Health and Family Welfare:**
* Impact: Responsible for enforcing the prohibition and ensuring compliance.
* Action Required: Monitor the implementation of the ban and address any arising issues.
Key Entities Referenced
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
Antibody Detecting Rapid Diagnostic Tests: A type of diagnostic test for Malaria that detects antibodies.
Malaria: An infectious disease caused by parasites transmitted via mosquito bites.
Drugs and Cosmetic Act, 1940: An act of the Parliament of India which regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Expert Committee: A committee appointed by the Central Government to examine the matter of Antibody Detecting Rapid Diagnostic Tests.
G.S.R. 577E: Notification number related to the principal notification, dated 23rd July, 1983.
G.S.R. 390E: Notification number of the last amendment, dated 24th April, 2018.
Dr. Mandeep K Bhandari: Jt. Secy. who signed the notification.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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6432 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[फा. सं. X-11014/15/2017-डीआरएस]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th October, 2018
G.S.R. 1074(E).—Whereas the Central Government is satisfied that the use of Antibody Detecting
Rapid Diagnostic Tests for diagnosis of Malaria as serological testing is not practical for routine diagnosis of
acute Malaria due to time required for development of antibody, the persistence of antibodies after clearance
of an active infection and the fact that serology does not detect current infection but measures past exposure;
And whereas, malaria antibody detection is performed using the indirect fluorescent antibody test for
a patient who is infected with Plasmodium, and because of the time required for development of antibody and
also the persistence of antibodies, serologic testing is not practical for routine diagnosis of acute malaria;
And whereas, there is a rampant use of Antibody Detecting Rapid Diagnostic Tests due to low cost
and free availability of these tests;
And whereas, the false positive rate in the endemic areas is also high as patients with fever due to
other reasons, who test negative by antigen detection, test positive by Antibody Detecting Rapid Diagnostic
Tests;
And whereas, the only tests used in diagnosis are Antigen Detecting Rapid Diagnostic Tests and
blood smear examination, and, therefore, there would not be any problems faced for malaria diagnosis by
banning the Antibody Detecting Rapid Diagnostic Tests;
And whereas, the matter has been examined by an Expert Committee appointed by the Central
Government and the said Expert Committee recommended to the Central Government that the said Antibody
Detecting Rapid Diagnostic Tests are found to have no justification for diagnosis of acute malaria;
And whereas on the basis of the recommendations of the said Expert Committee, the Central
Government is satisfied that it is necessary and expedient to prohibit the use of the Antibody Detecting Rapid
Diagnostic Tests for diagnosis of malaria in public interest;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
Now, therefore, in exercise of the powers conferred by section 10A of the Drugs and Cosmetic Act,
1940 (23 of 1940), the Central Government hereby makes the following amendment in the notification of the
Government of India in the Ministry of Health and Family Welfare No. G.S.R. 577(E), dated the 23rd July,
1983, namely:-
In the table below to the said notification, after serial number 12 and the entry relating thereto, the
following serial number and entry shall be inserted, namely:-
"13. Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria.”.
[F. No. X-11014/15/2017-DRS]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note : The principal notification was published in the Gazette of India vide G.S.R. 577(E), dated the
23rd July, 1983 and last amended by G.S.R. 390(E), dated the 24th April, 2018.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.